Data Management leadership on studies and take responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. Assume responsibility for all DM activities (from study start-up to database lock) according to client quality expectations, within project timelines and budgets. Act as subject matter expert (SME) for DM activities in relationship meetings with Sponsors. Work directly with Sponsors to understand their direct requirements and lead implementation of those requirements. Regularly review client specific process to ensure they remain optimal for Sponsor and Fortrea. The Senior Clinical Data Manager will work with the leadership team to provide guidance, mentoring and training to DM to ensure best working practices are maintained.
Summary of Responsibilities:
Develop the Vendor Data Plan (VDP), including the Data Quality Review reconciliation section, or sponsor equivalent, for the external vendor data transfer(s), obtain final approvals and file document to the Trial Master File (TMF) as applicable. May participate in review of external vendor Statement of Work (SOW) for study scope, and ensure all protocol specified parameters are present as applicable.
Ensure electronic external vendor data transfers contain all protocol specified parameters, is in correct format, and data populates to the specified fields and subjects correctly as designated in the Vendor Data Plan (VDP) or sponsor equivalent.
Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines. Ability to organize and effectively prioritize workload and deliverables.
As the Study Manager, be accountable for all DM deliverables as assigned per the established timeline; providing instruction to their DM study team(s) and review of their study team’s output to ensure the highest quality, while adjusting resource allocations accordingly.
Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
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Work with the Project Manager(s) or FSP Lead (or designee) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary, including at study initiation meetings.
Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of EDC Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager or FSP Lead (or designee) apprised of project progress.
Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on DM resources or deliverables and consult with Project Manager (or designee) and/or functional group management as necessary.
Keep Project Manager (or designee), Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e., budget status, work scope changes, timeline impacts).
Coordinates the receipt and inventory of all data related information, from clinical sites and vendors as appropriate to meet timelines for deliverables. Ensure all appropriate documentation and procedures are performed upon project completion.
Develop and maintain client relationships and review client satisfaction surveys. Implement appropriate action plans including driving process improvements and team training.
Track scope changes and work with the Project Manager or FSP Lead (or designee) to ensure that Sponsor approval is received, and the scope change processed.
Provides leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround durations to the internal study team.
Provide support to DM supervisors and managers on the performance evaluation of other team members, provide constructive feedback to aid in career development, interpersonal skills, and achievement of competency standards.
Accountable for learning new DM technologies and applied processes, keeping up to date with industry wide technology and feasibility for process improvement at Fortrea.
Ensures service and quality meet agreed upon specifications per the DMP and scope of work.
Have input in writing, reviewing, and updating SOPs and associated documents as required.
Maintain accurate records of all work undertaken.
Perform reconciliation of the clinical database against safety data, laboratory data or any other third-party data as appropriate. Utilize local laboratory systems and batch data load facilities where appropriate.
Represent DM and where necessary overall Biometrics in new business opportunities.
Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team.
Works with management team to develop and implement directional strategy by providing technical input into discussions and rolling out training/mentorship to DM staff (as required).
Actively promote Biometrics services to sponsors whenever possible.
Performs other related duties as assigned by management.
All other duties as needed or assigned.
Qualifications (Minimum Required):
University / college degree.
Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Language Skills Required:
Speaking/Writing/Reading: English required.
Experience (Minimum Required):
8 years of combined early or late-stage DM experience with minimum 2 years of direct sponsor management and at least 2 years technical mentoring experience. Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets.
Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
Proven ability to lead by example on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.
Time management skill and ability to adhere to project productivity metrics and timelines.
Ability to work in a team environment and collaborate with peers.
Ability to mentor junior members of the department, providing SME guidance on DM practices.
Experience of representing DM in bid defense meetings, providing innovative solutions to meet client needs.
Good organizational ability, communication, and interpersonal skills.
Constructive problem-solving attitude while deadline focused with time demands, incomplete information or unexpected events.
Preferred Qualifications Include:
University / college degree (life sciences, health sciences, information technology or related subjects preferred).
Through knowledge of Fortrea, the overall structure of the organization and Standard Operating Procedures (SOPs).
Four or more years of Electronic Data Capture experience.
Physical Demands/Work Environment:
Role is office or remote-based, with associated risks of repetitive strain injury (associated with keyboard operation) and eye strain (associated with VDU screen operation).
Potential travel for cross-site support or training needs, meetings up to 10% of the time, with up to 50% of that time requiring an overnight stay.
Learn more about our EEO & Accommodations request here.
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